TAILIEUCHUNG - Women Sufficiently Represented in New Drug Testing, but FDA Oversight Needs Improvement

United Nations agencies and global funding initiatives (such as the Global Fund and PEPFAR) have fundamental responsibility for realizing the potential of comprehensive services to prevent vertical transmission of HIV. These entities must be funders, coordinators, technical advisors and global champions. The research in the six countries covered in this report suggests that although several global entities have made important contributions to delivery of comprehensive services, their individual impacts have been constrained by insufficient linkages and collaboration. Taken together, these fragmented contributions have not led to the kind of robust, consistent programming needed to ensure rapid and sustainable improvements | United States General Accounting Office GAO Report to Congressional Requesters July 2001 WOMEN S HEALTH Women Sufficiently Represented in New Drug Testing but FDA Oversight Needs Improvement GAO-01-754 Contents Letter 1 Results in Brief 2 Background 5 FDA s Regulation Not As Specific As Earlier Guidance 10 NDA and IND Submissions Often Fail to Present Required Information 12 NDAs Include Appropriate Numbers of Women but Analyses Sometimes Missing 13 FDA Oversight Needs Improvement 17 Conclusions 19 Recommendations for Executive Action 20 Agency Comments 20 Appendix I Objectives Scope and Methodology 22 Appendix II Estimates of the Number of Men and Women in Clinical Drug Trials 27 Appendix III Comments From the Food and Drug Administration 32 Appendix IV GAO Contact and Staff Acknowledgments 35 Related GAO Products 36 Tables Table 1 NDAs With Evidence of Sex-Related Analyses 15 Table 2 NDAs That Reported Differences Between Men and Women. 16 Table 3 NDAs That Reported Differences in Drug Response Between Women Using the Test Drug and Women in the Comparison Group 16 Table 4 Medical Officer Reviews Not Discussing Sponsor-Reported Sex-Related Analyses of Differences in Drug Response 18 Page i GAO-01-754 Women in Clinical Drug Trials Table 5 Decision Rules for Collection of Data From NDA Critical Summary Documents. 23 Table 6 Description of the IND Annual Report Sample 24 Table 7 Estimate of Women and Men in Clinical Drug Trials by Drug Class 28 Table 8 Estimate of Men and Women in Pivotal Drug Trials by Drug Class 30 Figure Figure 1 Participants in Clinical Drug Trials by Sex 4 Abbreviations DES diethylstilbestrol FDA Food and Drug Administration IND investigational new drug IOM Institute of Medicine NDA new drug application NME new molecular entity OTC over-the-counter PPA phenylpropanolamine Page ii GAO-01-754 Women in Clinical Drug .

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